Clinical Trial Manager

Kelly Science, Engineering, Technology & Telecom; United States; On-site; USD 80,000 - 110,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Study Manager to support global pharmaceutical partners. This role involves leading clinical trial executions, managing teams, and ensuring operational deliverables are met. Ideal candidates will have at least 2 years of experience in pharmaceutical drug development, strong skills in MS Project and Excel, and a relevant educational background. Join us to contribute to impactful studies in the field.

Qualifications

• Minimum 2 years experience as a lead Study Manager.
• Proven ability to meet aggressive timelines.
• TA-specific experience is beneficial.

Responsibilities

• Lead or support clinical trials as operational point of contact.
• Manage all HQ Operational Activities and Clinical Trial Team.
• Oversee protocol training and recruitment planning activities.

Skills

Pharmaceutical and clinical drug development experience

MS Project

Excel

Presentation skills

Project management

Oral and written communication

Education

BS/BA/MS/PhD with 7+ years clinical research experience

Job description

Join Kelly FSP as a Senior Study Manager supporting our global pharmaceutical partner!

Senior Study Manager

Description of Services

• May lead or support a study or studies, depending on size/complexity. As lead, will be responsible for the following:Operational point of contact for trial execution and all trial deliverables
• Manages all HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) Supports clinical (drug/vaccine) supplies planning
• Manages deployment and interactions with external vendors (e.g., IVRS, PRO)
• Initiates planning for Investigator meeting and protocol training.
• Plans and assesses protocol ancillary supplies
• Completes trial set-up and maintains SPECTRUM
• Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT
• Initiates recruitment/retention planning & enrollment tracking
• Responsible for tracking study related details (e.g., specimens, queries)
• Oversees protocol training activities including IMs and CRAs training meetings
• Ensures appropriate postings to investigative site portals
• Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others)
• Point of escalation for study related operational issues
• Responsible for creating and maintaining project schedule and collaborating with Program Lead
• Sets up and maintains Trial Master File (eTMF)
• Ensures alignment of budget with protocol needs
• Responsible for executing protocol within the budget
• Responsible for risk assessment, mitigation planning and execution
• Responsible for creating and maintaining ADI logs
• Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group
• Develops study related manuals (e.g., administrative binder, lab manuals)
• Manages Emergency Unblinding (EUB) Call Center activities
• Co-authors newsletters with CS
• Approves contracts, invoice payments and change orders for vendors, as necessary
• Responsible for end of study reconciliation (clinical & ancillary supplies)
• Oversees all HQ close-out tasks
• Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking
• Supports CS activities as needed to achieve CTT deliverables
• Interface with External Data Coordination and Data Management
• Responsible for quality control and inspection readiness at all times

Minimum Years of Experience:

• Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead SM required
• Proven ability to meet aggressive timelines
• MS Project experience preferred
• Excellent Excel and PP skills required
• TA-specific experience beneficial
• Excellent oral (including presentation) and written communication, computer/database management, and project management skills required

Educational Requirements

• BS/BA/MS/PhD with 7+ yrs clinical research experience